Zydus Lifesciences Limited has informed the Exchange regarding a press release dated October 06, 2025, titled "Zydus receives final approval from USFDA for Deflazacort oral suspension, 22.75 mg/mL".
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Zydus Lifesciences has received final approval from the USFDA to market Deflazacort oral suspension in the strength of 22.75 mg/mL in the United States. Deflazacort is a corticosteroid used to treat conditions like Duchenne muscular dystrophy and inflammatory disorders. This approval adds another product to Zydus's growing portfolio of US generic drugs, reinforcing its presence in the US pharmaceutical market. The company will now be able to manufacture and commercialise this formulation through its US subsidiary.
Positive for the stock — USFDA approvals directly support Zydus's US business revenue, and each new product launch strengthens its generic pipeline and long-term growth outlook.